Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Launched by ICHNOS SCIENCES SA · May 7, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called ISB 2001 for patients with relapsed or refractory multiple myeloma, which means their cancer has returned or not responded to previous treatments. This is an early-stage study to see how safe ISB 2001 is and how well it works in fighting this type of cancer. The trial is currently looking for participants aged 65 to 74 years old, and anyone of any gender can join.

To be eligible for the study, participants need to have a confirmed diagnosis of multiple myeloma with measurable signs of the disease. They should also have a good level of overall health, indicated by a performance status score of 2 or less, which means they can carry out daily activities with some limitations. Participants will receive the treatment and be closely monitored for any side effects or changes in their condition. It's important to note that individuals with certain health issues, infections, or those who are pregnant or breastfeeding are not eligible to participate. This trial aims to provide valuable insights into a new potential treatment for multiple myeloma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
• • 2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
• • 3. Must have adequate hematologic, hepatic, renal, and cardiac functions
• Exclusion Criteria:
• • 1. Active malignant central nervous system involvement
• • 2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
• • 3. History of autoimmune disease requiring systemic immunosuppressive therapy
• • 4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.
• • 5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.